Evaluating the effects of Anti-Tuberculosis Therapy in patients with idiopathic uveitis
Proportion of Clinical Improvement and Score Comparison of Type 1 Interferon, Transcriptomic Analysis in Idiopathic Uveitis Patients With IGRA Positive Before and After Anti-Tuberculosis Drugs Treatment: Cohort Prospective Study
This study is testing if anti-tuberculosis treatment can help improve symptoms in people with unexplained eye inflammation who have a positive test for tuberculosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fakultas Kedokteran Universitas Indonesia Academic / other |
| Locations | 1 site (Jakarta Pusat, Jakarta) |
| Trial ID | NCT04088019 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the clinical improvement and changes in type 1 interferon gene expression in patients with idiopathic uveitis who test positive for the Interferon Gamma Release Assay (IGRA) after receiving Anti-Tuberculosis Therapy (ATT). The research will analyze transcriptomic profiling and clinical outcomes to determine the efficacy of ATT in this patient population. By comparing data before and after treatment, the study seeks to clarify the role of tuberculosis in idiopathic uveitis and identify potential biomarkers for treatment response.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with idiopathic uveitis who are IGRA positive and have not previously received Anti-Tuberculosis Therapy.
Not a fit: Patients with active tuberculosis or those who have previously undergone Anti-Tuberculosis Therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of Anti-Tuberculosis Therapy for patients with idiopathic uveitis, potentially improving treatment strategies.
How similar studies have performed: While there is limited data on the specific use of ATT in idiopathic uveitis, similar studies exploring the relationship between tuberculosis and uveitis have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: Subjects who will be recruited to this study are patients who met the criteria described below: * Registered patients from September 2019 at Cipto Mangunkusumo Hospital * Idiopathic uveitis patients (proven having negative result by available etiological uveitis work-ups) with IGRA positive. IGRA positive value is defined by score above 0.35 u/ml obtained from Quantiferon Tuberculosis (QFT)-Gold Assay (QIAGEN). * Minimum age: 18 years old * Proven not having active Tuberculosis * Not previously received Anti Tuberculosis Therapy. * Not consuming antibiotic one to two weeks prior to the time of study * Not living together with Tuberculosis active patient * Not having plan to become pregnant during the time of study * Not part of reactive Tuberculosis risk group based on Latent Tuberculosis Incident WHO guidelines 2018 * Active inflammation in the past 180 days characterized by the following sign based on SUN Criteria(in at least one eye) * ≥ 2+ anterior chamber cells * ≥ 2+ vitreous haze * active retinal or choroidal lesions * Active inflammation during patient registration, characterized by the following sign based on SUN Criteria (in at least one eye) * ≥1+ anterior chamber cells and/or * ≥1+ vitreous haze and/or * active retinal/choroidal lesions Exclusion Criteria: * Not willing to sign informed consent * Pregnant patient * Not coming to scheduled visit date * Uveitis caused by infectious origin * Media opacity caused by cataract and/ or corneal scar resulting in difficulty of posterior segment examination in both eyes * Chronic hypotony (IOP \< 5 mm Hg for \> 3 months) in both eyes * History of prior intraocular surgery in \< 30 days, or arranged surgery within the next 6 months * Best spectacle-corrected visual acuity (BSCVA) of hand motions or worse in better eye * Any history of cancer excluding non-melanoma skin cancer * Abnormal Complete blood count (≤ 2,500 white blood cells and/or ≤ 75,000 platelets and/or ≤9 hemoglobin) within 4 weeks prior to enrollment\^ * Abnormal alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal for the lab and/or creatinine ≥ 1.5 within 4 weeks prior to enrollment\^ * Patient with active infection of tuberculosis, HIV infection, syphilis, or hepatitis B or C Note (\^): Testing is conducted within 1-2 weeks prior to enrollment; As many 10 subjects of the health volunteers are recruited for this study after giving consent. The health volunteers that will be recruited are the subject who met following criteria: 1. age: 18-50 years old (Man/Woman) 2. not having any health complaint or symptoms 3. not in any long term medication 4. body mass index: 18.5 - \< 30 5. no history of allergy 6. willing to cooperate in this study 7. state of complete physical, mental, and social well being, and not merely the absence of disease or infirmity (WHO healthy definition)
Where this trial is running
Jakarta Pusat, Jakarta
- RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital) — Jakarta Pusat, Jakarta, Indonesia (Recruiting)
Study contacts
- Principal investigator: Rina La Distia Nora — Division of Ophthalmology Departement, Faculty of Medicine Universitas Indonesia
- Study coordinator: Rina La Distia Nora
- Email: rina.ladistia@ui.ac.id
- Phone: +62811-198-910
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.